FDA Approvals

FDA approves drug for pregnant women with HIVFDA recently approved an expansion to the prescribing information for darunavir (Prezista, Janssen Therapeutics), to treat pregnant women with HIV.
New weight management pill available soonFDA recently approved the New Drug Application (NDA) for (lorcaserin HCl) CIV extended-release 20 mg tablets (Belviq XR, Eisai Inc. and Arena Pharmaceuticals), a once-a day dosing option for chronic weight management.
FDA approves first once-monthly injection to lower cholesterolFDA approved evolocumab (Repatha, Amgen) Pushtronex system, the first monthly single-dose injection of a PCSK9 inhibitor. Repatha was already approved by FDA as the only PCSK9 inhibitor with a monthly dose last August.
Top 4 ways US is combating opioid epidemic
Top 4 ways US is combating opioid epidemicExpanding access to buprenorphine, a medication to treat opioid use disorder, is one of several new actions announced by Health and Human Services (HHS) to combat the opioid epidemic. Here are the top 4 new provisions from HHS.
FDA approves cannabis-derived drugFor the first time, FDA approved dronabinol oral solution (Syndros, Insys Therapeutics), a liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC").
Cheaper hep C drug enters competitive market
Cheaper hep C drug enters competitive marketA new drug approved by FDA to treat chronic hepatitis C virus (HCV) infection this week enters a competitive, lucrative market headed up by Gilead Science’s Sovaldi and Harvoni, as well as AbbVie’s Viekira Pak. FDA granted priority review and breakthrough therapy designation to Gilead’s combination product, Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg).
Zika vaccine on the horizonThe U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) plans to help bring a vaccine for the Zika virus to market immediately via Emergent BioSolutions Inc., which also developed the anthrax vaccine.
FDA approves rare liver disease drugFDA recently granted accelerated approval for obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis.
FDA approves first treatment for acute GVHDFDA just granted Breakthrough Therapy Designation for the first treatment for acute graft-versus-host disease (GVHD): ruxolitinib (Jakafi, Incyte Corp.).
FDA approves novel kidney disease drugAfter initially rejecting calcifediol (Rayaldee, Opko Health) for chronic kidney disease earlier this year because of manufacturing concerns, FDA approved the drug four months ahead of its new timeline. Rayaldee extended release capsules is the first drug to receive FDA approval for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.